Effect of Methylprednisolone on Orthostatic Intolerance and Heart Rate Variability in Hip-arthroplasty Patients

January 17, 2017 updated by: Viktoria Oline Lindberg-Larsen, Rigshospitalet, Denmark

Effect of Preoperative Intravenous High Dose Methylprednisolone on Orthostatic Intolerance and Heart Rate Variability in Patients Scheduled for Total Hip-arthroplasty

The study evaluates the pathophysiological effects of a single dose Methylprednisolone administered prior to total hip-arthroplasty (THA) surgery. The investigators examine the effect on orthostatic intolerance, orthostatic hypotension and heart rate variability (HRV) to evaluate the efficacy of Methylprednisolone regarding blood pressure regulation and autonomic responses after THA.

Half of participants will receive intravenous Solu-Medrol 125 mg, while the other half will receive placebo.

The investigators hypothesize that the group receiving Methylprednisolone will be less orthostatic intolerant, experience less orthostatic hypotension and have an improved autonomic response compared to the placebo-group, early after THA.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The anti-inflammatory effects of glucocorticoids are well known. The beneficial effects in postoperative pain, postoperative nausea and vomiting are well-documented.

Hip-arthroplasty surgery and the inflammatory stress response in general affect the potential of recovery. Early postoperative orthostatic intolerance is common in patients undergoing THA with an incidence of 40%. The mechanism is thought related to an impaired autonomic regulation caused by surgery-induced inflammation. The effect of glucocorticoids on orthostatic intolerance, orthostatic hypotension and HRV after hip-arthroplasty surgery is unknown and calls for further investigation.

The study is to be considered as exploratory. The primary analysis of the primary outcome measure is a comparison of the incidence of orthostatic intolerance from baseline to 6 hours postoperatively between the two groups.

For calculation of sample size the difference in incidence between groups (40% versus 10%) from baseline (before surgery) to 6 hours after THA-surgery, a risk of type I errors 5% and a risk of type II errors 20% (80% power) were used.

The primary analysis is carried out on all included patients (intention-to-treat) with baseline values as covariate. Secondary exploratory per-protocol analysis might be performed. Missing outcomes will be analysed using multiple imputation due to expected strong time trends.

The secondary outcomes measures; Non-invasive blood pressure, systemic vascular resistance, cardiac output, HRV, plasma-hemoglobin, C-reactive protein.

For further details please also view the European Clinical Trials Database (EudraCT) registration:

EudraCT nr.: 2015-000102-19

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen NV, Denmark, 2400
        • Copenhagen University Hospital, Bispebjerg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Osteoarthrosis
  • Undergoing total unilateral hip-arthroplasty surgery
  • Speak and understand Danish
  • Have given informed content

Exclusion Criteria:

  • Revision or bilateral hip-arthroplasty surgery
  • General anaesthesia
  • Allergy or intolerance towards Methylprednisolone
  • Local or systemic infection
  • Permanent systemic treatment with steroids within 30 days peroperatively
  • Insulin-dependent diabetes
  • Atrial fibrillation
  • Neurological disease incl. Parkinsons
  • Daily use of hypnotics or sedatives
  • Alcohol abuse >35 units per week
  • Active treatment of ulcer within 3 months preoperatively
  • Cancer disease
  • Autoimmune disease incl. rheumatoid arthritis
  • Pregnant or breast feeding women
  • Menopause <1 year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Methylprednisolone
Preoperative single high dose of Solu-Medrol 125 mg iv.
Drug: Methylprednisolone
Comparison of preoperative single high dose of Methylprednisolone 125 mg iv. and isotonic Sodium Chloride (placebo)
Other Names:
  • Solu-Medrol
Placebo Comparator: Isotonic Sodium Chloride
Preoperative single dose of isotonic Sodium Chloride
Drug: Isotonic Sodium Chloride
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference in incidence of orthostatic intolerance from baseline to 6 hours after surgery
Time Frame: 6 hours after surgery
6 hours after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Difference in incidence of orthostatic intolerance from baseline to 24 hours after surgery
Time Frame: 24 hours after surgery
24 hours after surgery
Change in non-invasive blood pressure from baseline to 24 hours after surgery
Time Frame: 24 hours after surgery
24 hours after surgery
Change in heart rate variability from baseline to 24 hours after surgery
Time Frame: 24 hours after surgery
24 hours after surgery
Change in stroke volume and cardiac output from baseline to 24 hours after surgery
Time Frame: 24 hours after surgery
24 hours after surgery
Change in systemic vascular resistance from baseline to 24 hours after surgery
Time Frame: 24 hours after surgery
24 hours after surgery
Change in pain intensity from baseline to 24 hours after surgery
Time Frame: 24 hours after surgery
24 hours after surgery
Change in concentration of plasma-hemoglobin from baseline to 48 hours after surgery
Time Frame: 48 hours after surgery
48 hours after surgery
Change in concentration of C-reactive protein from baseline to 48 hours after surgery
Time Frame: 48 hours after surgery
48 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

Bispebjerg Hospital

Investigators

  • Principal Investigator: Viktoria Lindberg-Larsen, MD, Section for Surgical Pathophysiology, Rigshospitalet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

May 13, 2015

First Submitted That Met QC Criteria

May 14, 2015

First Posted (Estimate)

May 15, 2015

Study Record Updates

Last Update Posted (Estimate)

January 18, 2017

Last Update Submitted That Met QC Criteria

January 17, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HK_VL_01_2015
  • 2015-000102-19 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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